Transplant Trial Watch

Cost-effectiveness of everolimus plus reduced tacrolimus in de novo liver-recipients in the Italian setting.

Bianic F, Campbell R, et al.

Journal of Medical Economics 2016; 19(9):866-73


Aims
To examine the cost-effectiveness of everolimus (EVR) plus reduced-dose TAC (rTAC) compared to standard-dose TAC alone in de novo liver-recipients.

Interventions
A Markov model simulating both liver and kidney function was developed. All patients entered the model at day of transplant and after 30 days were randomized to receive either EVR plus rTAC, or TAC standarddose.

Participants
de novo liver transplant recipients aged ≥18 years who received a primary allograft from a deceased donor.

Outcomes
The primary outcome measured was the incremental cost-effectiveness ration (ICER). Secondary measured outcomes were life years (Lys) and quality adjusted life years (QALY).

Follow-up
3 years

CET Conclusions
This paper reports the results of a cost effectiveness analysis of reduced tacrolimus exposure with everolimus in liver transplant recipients. It utilises clinical data from the multinational H2304 study, but reports cost-effectiveness from an Italian healthcare payer perspective. Using a Markov model simulating liver and renal function in liver transplant recipients, the authors demonstrate a benefit of 1.62 quality-adjusted life years (QALYs) with the everolimus regimen. The cost per QALY is €42,567, which is just above the upper threshold of €40,000 recommended by the Italian Association of Health Economics. However, in the subgroup of patients with liver failure du to hepatitis C, the incremental cost per QALY was lower, at €30,658. These results suggest that the everolimus regimen does improve quality-adjusted life expectancy in liver transplant recipients, and whilst not cost-effective in all patients, may be in those with HCV. They should however be interpreted with caution, as the analysis comes from Novartis (the manufacturer of Everolimus) and are limited to the Italian healthcare setting.

Quality notes
Quality assessment not appropriate

Trial registration
None

Funding source
Industry funded